(181 days)
The Axle Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1 inclusive). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The Axle Interspinous Fusion System is intended for use with bone graft material, and not for stand-alone use.
The Axle Interspinous Fusion System consists of plates and inserts of various sizes that are used to provide supplemental stabilization of the spinous processes to support fusion. The system components can be assembled in a variety of configurations so that adaptations can be made to take into account pathology and individual patient anatomy. The implant components are provided clean and non-sterile.
The provided text describes a medical device, the "Axle™ Interspinous Fusion System," and its clearance by the FDA based on substantial equivalence to a predicate device. The information primarily focuses on the device's design, intended use, and biomechanical testing to demonstrate performance.
Here's an analysis of the provided information against your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Measured Performance) | Reported Device Performance |
|---|---|
| Mechanical Performance: - Static Compression Bending - Static Torsion - Fatigue Compression Bending | "Biomechanical testing results indicate that the Axle Interspinous Fusion System is substantially equivalent to predicate device performance and is capable of safely and effectively performing in accordance with its intended use." (Specific numerical values or thresholds for performance are not provided in this summary, but the claim is one of equivalence to the predicate device, Medtronic CD Horizon Spinal System (K091445), specifically the Medtronic SPIRE Spinous Process Plate component.) |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "biomechanical testing" and refers to "ASTM F1717 – Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model." This is a laboratory-based biomechanical test, not a clinical study involving human patients. Therefore, the concept of "test set sample size" and "data provenance" in terms of patient data (country of origin, retrospective/prospective) is not applicable here. The samples would be the physical implant constructs tested in the lab. The number of samples tested for each biomechanical scenario is not specified in the provided text.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. This device's clearance is based on mechanical performance compared to a predicate device, not on diagnostic accuracy requiring human expert consensus.
4. Adjudication Method for the Test Set:
Not applicable. As described above, the evaluation is based on biomechanical testing against established ASTM standards and comparison to a predicate device's performance, not on subjective human assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. This is a spinal implant for fixation, not an image analysis or diagnostic AI device that would typically undergo an MRMC study. The evaluation focuses on physical characteristics and mechanical performance.
6. Standalone (Algorithm Only) Performance:
Not applicable. The "Axle Interspinous Fusion System" is a physical medical device, an implant, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. Type of Ground Truth Used:
The "ground truth" for this device's performance is established by the ASTM F1717 standard test methods for spinal implant constructs in a vertebrectomy model and the performance characteristics of the predicate device (Medtronic CD Horizon Spinal System, specifically the Medtronic SPIRE Spinous Process Plate component). The acceptance criteria are that the device's mechanical performance is substantially equivalent to the predicate performance when tested according to these standards.
8. Sample Size for the Training Set:
Not applicable. Since this is a physical medical device and not an AI/machine learning system, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set for an AI/machine learning model, the establishment of ground truth for such a set is irrelevant in this context.
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510(k) Summary
ADMINISTRATIVE INFORMATION NOV 2 4 2010 X-spine Systems, Inc. Manufacturer Name: 452 Alexandersville Rd. Miamisburg, OH 45342 Telephone (937) 847-8400 FAX (937) 847-8410 David Kirschman, M.D. Official Contact: Chief Medical Officer May 26, 2010 Date Prepared: DEVICE NAME Axle™ Interspinous Fusion System Trade/Proprietary Name: Interspinous Process Fixation System Common Name: Spinal Interlaminal Fixation Orthosis Classification Name: Device Class: Class II $888.3050 Classification: KWP Product Code:
ESTABLISHMENT REGISTRATION NUMBER
X-spine Systems, Inc. has submitted an Establishment Registration to FDA. The Establishment Registration number is 3005031160. The owner/operator number for X-spine Systems, Inc. is 9063903.
INTENDED USE
The Axle Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1 inclusive). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The Axle Interspinous Fusion System is intended for use with bone graft material, and not for stand-alone use.
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DEVICE DESCRIPTION
The Axle Interspinous Fusion System consists of plates and inserts of various sizes that are used to provide supplemental stabilization of the spinous processes to support fusion. The system components can be assembled in a variety of configurations so that adaptations can be made to take into account pathology and individual patient anatomy. The implant components are provided clean and non-sterile.
EQUIVALENCE TO MARKETED PRODUCT
X-spine Systems, Inc. has submitted information to demonstrate that, for the purposes of FDA's regulation of medical devices, the Axle Interspinous Fusion System is substantially equivalent to the Medtronic CD Horizon Spinal System (K091445), specifically the Medtronic SPIRE Spinous Process Plate component, based on a technological comparison including the following characteristics:
- FDA Product Code .
- . Intended Uses
- Surgical Approach
- Anatomical Region ●
- Implant Materials
- Product Dimensions .
- Mechanical Performance .
PERFORMANCE DATA
The implant components were tested using the following standards:
ASTM F1717 – Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
- . Static Compression Bending
- Static Torsion .
- . Fatigue Compression Bending
In conclusion, biomechanical testing results indicate that the Axle Interspinous Fusion System is substantially equivalent to predicate device performance and is capable of safely and effectively performing in accordance with its intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
X-spine Systems, Inc. % David Kirschman, M.D. Chief Medical Officer 452 Alexandersville Rd. Miamisburg, Ohio 45342
NOV 2 4 2010
Re: K101471
Trade/Device Name: Axle Interspinous Fusion System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: November 10, 2010 Received: November 12, 2010
Dear Dr. Kirschman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act
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Page 2 - David Kirschman, M.D.
or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/Reportal?roblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Milkereit
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Axle Interspinous Fusion System
Indications for Use - REVISED
NOV 2 4 2010
510(k) Number (if known): Klommi
Device Name: Axle™ Interspinous Fusion System
Indications for Use:
The Axle Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1 inclusive). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The Axle Interspinous Fusion System is intended for use with bone graft material, and not for stand-alone use.
Prescription Use × (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sign Off
AND/OR
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KI01471 510(k) Number_
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.